PET-Adapted First-Line Therapy With Nivolumab for Advanced Hodgkin Lymphoma

Korábbi kezelés

• Prior or active autoimmune disease requiring systemic therapy
• Vaccination with a live vaccine within 30 days prior to first nivolumab dose

Más betegség

• Active hepatitis B or C infection
• Positive test for HIV
• History of non-infectious pneumonitis requiring corticosteroids
• Prior malignancy (except for adequately treated basal cell carcinoma or cervical carcinoma in situ)
• Congestive heart failure, unstable angina, recent myocardial infarction, or severe cardiac arrhythmias
• Severe pneumonia with respiratory failure or hypoxemia not corrected within 2-3 days
• Life-threatening bleeding events (e.g., gastrointestinal or cerebral hemorrhage)
• Decompensated diabetes mellitus
• Any somatic or psychiatric condition that, in the investigator's judgment, precludes informed consent or study participation

Laborértékek

• Severe renal impairment (serum creatinine \> 0.2 mmol/L), unless lymphoma-related
• Cachexia (total serum protein \< 35 g/L), unless due to lymphoma-related liver damage

Egyéb

• Pregnancy or breastfeeding
• Severe hepatic dysfunction, unless directly related to lymphoma
• Sepsis or hemodynamic instability

• Signed written informed consent prior to any study-specific procedures
• Histologically confirmed classical Hodgkin lymphoma (cHL)
• Newly diagnosed disease, Ann Arbor stage IIB (bulky), III, or IV
• At least one measurable lesion ≥15 mm in the longest diameter (by CT)
• Age between 18 and 60 years (inclusive)
• ECOG performance status 0-2
• PET-CT performed at baseline
• No prior chemotherapy, radiotherapy, or immunotherapy for lymphoma
• Adequate organ function, including:
• Serum creatinine ≤ 0.2 mmol/L
• Absence of severe cardiac, pulmonary, hepatic, or renal dysfunction
• Ability to comply with the study protocol and scheduled visits